Pre-Market Quality and Regulatory Specialist (m/f/d)

Do you want a job with a purpose?

And do you want to make healthcare safer, better and more reliable?

Join our Team!

We are looking for you, located in Bonn, Vienna or Bordeaux as an

Pre-Market Quality and Regulatory Specialist (m/f/d)

Your tasks:

• Ensuring process adherence for the pre-market procedures
• Completeness of design history files and regulatory submissions
• Regulatory and process conformance for development and maintenance projects as a member of cross-functional teams
• Creation and maintenance of key regulatory deliverables of the projects
• Regulatory and CE submissions in cooperation with regional QARA organizations
• Ensuring the adherence to the medical device risk analysis process as risk moderator of the

• Facilitate regulatory compliance in design control processes to ensure that there are no compliance issues during regulatory inspections
• Performing internal audits and defending Dedalus pre-market activities during external regulatory inspections and audits
• Be a QARA ambassador on product teams

You bring along:

• University Degree (Engineering, Computer science or Science) or equivalent
• Minimum 3 years of experience in a regulated industry – preferably medical device, pharmaceutical or related – holding a position in project management, quality management, or quality assurance and regulatory affairs position.
• Ability to analyse, understand, and interpret regulations and standards for a more general business audience
• Subject matter expert in regulatory affairs with in-depth knowledge of relevant health care quality standards and requirements including ISO 13485, ISO 14971, IEC 62304, IEC 62366, Medical Device Directive, and new Medical Device Regulation MDR and IVDR
• Knowledge of and experience in: Design control regulations and requirement, Medical device classification rules and regulations, Medical device regulatory submission regulations and requirements, Risk management regulations and requirements, Software development methodologies and practices, CAPA/NC regulations and requirements, Usability, safety, and product related standards
• Awareness of Medical Device product safety and Security Standards including ISO 27001, GDPR (Preferable)
• Awareness of other regulation as determined by product availability (including ANVISA, CMDCAS, FDA, SFDA)
• Strong problem solving and project management skills as well as excellent communication (verbal and written), research, organizational and interpersonal skills
• Ability to work independently towards deadlines and strong attention to detail
• Expert PC operation skills, including knowledge of enterprise-wide software applications
• Knowledge of Microsoft Office applications required (Intermediate to Advanced preferred)
• QMS tools (document & records control systems, regulatory clearances, KPIs) (Preferable)
• Mandatory Language Skills: English (upper intermediate or better)

What we offer:

• A permanent employment contract with an attractive salary for a long-term perspective
• Flexible working hours and working time models - a balance between job and quality of life
• Responsible and exciting tasks in a future-oriented industry
• Friendly colleagues who are happy to support you
• Up-to-date company mobile phone with dual sim (Android or iOS) also for private use
• Free parking spaces
• Free drinks and weekly fruit basket
• Job ticket ("Deutschlandticket")
• Group accident insurance (also valid for accidents during leisure time)
• Company pension scheme

Be part of our innovative power and shape the future with us!

#teamdedalus #together4success #dedalusgroup

We are looking forward to receiving your online application!

Severely disabled applicants will be given special consideration if they are equally qualified.

Dedalus HealthCare GmbH

Human Resources

Konrad-Zuse-Platz 1-3

53227 Bonn

https://www.dedalusgroup.de